Evaluating the Effectiveness of an ACT-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain

Chronic Pain Clinical Trial

Official title:

A Randomized Controlled Trial Evaluating the Effectiveness of an Acceptance and Commitment Therapy-Based Bibliotherapy Intervention Among Adults Living With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03924687
• Other study ID #: CER-15-215-07.23
• Status: Completed
• Phase: N/A
• Start date: March 28, 2016
• Est. completion date: August 2016

Study information

• Verified date: April 2019
• Source: Université du Québec à Trois-Rivières
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic pain has a significant impact on the physical and psychological functioning of those living with this condition. It is now recognized that Acceptance and Commitment Therapy (ACT) is an effective intervention in managing chronic pain; however, several barriers limit its accessibility.

The current study aims to evaluate the effectiveness of an eight-week bibliotherapy-type self-administered psychological intervention with minimal therapeutic contact, based on ACT, in the management of chronic pain.

This study is a randomized controlled trial with two groups (one experimental group and one wait-list control group). Participants will be randomly assigned to each condition and measures will be taken at pretest, posttest and three months following the intervention.

Description:

The purpose of this randomized controlled trial was to assess the effectiveness of an eight-week self-administered intervention program (bibliotherapy) based on Acceptance and Commitment Therapy with minimal therapeutic support in the management of chronic pain.

This study was based on the following hypotheses. In comparison to the control group, from pre to post, the self-help program will:

1. significantly reduce pain-related disability (primary variable);

2. improve depressive symptoms related to CP (secondary variable);

3. increase the level of pain acceptance;

4. reduce psychological inflexibility linked to painful symptoms (process variables).

It was also expected that:

5. the improvements would be maintained at three-month follow-up;

6. participants would have an overall impression of a positive change following the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• being 18 years of age or older

• having suffered from daily pain for more than three months

• having reading and writing abilities in French equivalent or superior to grade 8

• having access to Internet at home and having a valid e-mail address

• not having previously completed an ACT-type psychotherapy, not having practiced mindfulness meditation regularly and not having read a bibliotherapy on ACT for pain

• having stable medication for at least one month, if applicable.

Exclusion Criteria:

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain
The intervention consisted of the book "Libérez-vous de la douleur par la méditation et l'ACT" (Dionne, 2014) and a participant workbook, along with two phone calls of approximately 15 minutes each and weekly e-mails presenting the week's content. Participants also had access to audio meditation exercises on the book's website (http://liberezvousdeladouleur.com/meditations/).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université du Québec à Trois-Rivières

References & Publications (6)

Boulanger, A., Charbonneau, C., Choinière, M., Laliberté, J., & St-Hilaire, F. (2015). Renforcer les services de première ligne, développer les connaissances et les compétences des patients et des professionnels de la santé afin de mieux prévenir et traiter la douleur chronique.

Hann, K. E. J., & McCracken, L. M. (2014). A systematic review of randomized controlled trials of Acceptance and Commitment Therapy for adults with chronic pain: Outcome domains, design quality, and efficacy. Journal of Contextual Behavioral Science, 3(4), 217-227. http://dx.doi.org/http://dx.doi.org/10.1016/j.jcbs.2014.10.001

Hayes, S. C., Strosahl, K. D., & Wilson, K., G. (2012). Acceptance and commitment therapy : the process and practice of mindful change (2nd ed.). New York: Guilford Press.

Hogg MN, Gibson S, Helou A, DeGabriele J, Farrell MJ. Waiting in pain: a systematic investigation into the provision of persistent pain services in Australia. Med J Aust. 2012 Apr 2;196(6):386-90. — View Citation

Hughes LS, Clark J, Colclough JA, Dale E, McMillan D. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses. Clin J Pain. 2017 Jun;33(6):552-568. doi: 10.1097/AJP.0000000000000425. Review. — View Citation

Jamison RN, Gintner L, Rogers JF, Fairchild DG. Disease management for chronic pain: barriers of program implementation with primary care physicians. Pain Med. 2002 Jun;3(2):92-101. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain-related disability	Brief Pain Inventory (BPI; Interference subscale; Cleeland & Ryan 1994; Poundja, Fikretoglu, Guay, & Brunet 2007; Tyler, Jensen, Engel, & Schwartz 2002)	Change from week 1 to week 9
Primary	Change in Pain-related disability	Brief Pain Inventory (BPI; Interference subscale; Cleeland & Ryan 1994; Poundja, Fikretoglu, Guay, & Brunet 2007; Tyler, Jensen, Engel, & Schwartz 2002)	Change from week 9 and week 21 (ACT group only)
Secondary	Change in Depressive symptoms	The Beck Depression Inventory (BDI — Short Form: Beck, Rial, & Rickels 1974)	Change from week 1 to week 9
Secondary	Change in Depressive symptoms	The Beck Depression Inventory (BDI — Short Form: Beck, Rial, & Rickels 1974)	Change from week 9 and week 21 (ACT group only)
Secondary	Change in Pain acceptance	Chronic Pain Acceptance Questionnaire (CPAQ-8: Fish, McGuire, Hogan, Morrison, & Stewart 2010). The CPAQ-8 is an 8-item measure that evaluates acceptance of pain according to two sub-scales: activity engagement and pain willingness. Items are rated on a Likert scale from 0 = never true to 6 = always true. Total scores range from 0 to 48 and higher scores reflect greater acceptance of pain.	Change from week 1 to week 9
Secondary	Change in Pain acceptance	Chronic Pain Acceptance Questionnaire (CPAQ-8: Fish, McGuire, Hogan, Morrison, & Stewart 2010). The CPAQ-8 is an 8-item measure that evaluates acceptance of pain according to two sub-scales: activity engagement and pain willingness. Items are rated on a Likert scale from 0 = never true to 6 = always true. Total scores range from 0 to 48 and higher scores reflect greater acceptance of pain.	Change from week 9 and week 21 (ACT group only)
Secondary	Change in Psychological inflexibility	Psychological Inflexibility in Pain Scale (PIPS; Wicksell, Lekander, et al. 2010). The PIPS is composed of 12 items that evaluate two dimensions: avoidance and cognitive fusion. Items are rated on a Likert scale from 1 = never true to 7 = always true, to evaluate the level of inflexibility associated to pain. Scores range from 12 to 84, with higher scores revealing greater psychological inflexibility.	Change from week 1 to week 9
Secondary	Change in Psychological inflexibility	Psychological Inflexibility in Pain Scale (PIPS; Wicksell, Lekander, et al. 2010). The PIPS is composed of 12 items that evaluate two dimensions: avoidance and cognitive fusion. Items are rated on a Likert scale from 1 = never true to 7 = always true, to evaluate the level of inflexibility associated to pain. Scores range from 12 to 84, with higher scores revealing greater psychological inflexibility.	Change from week 9 and week 21 (ACT group only)
Secondary	Participants' impression of change	Patient Global Impression of Change (PGIC: Guy et al. 1976)	week 21